OTX-202 Smartphone App to Reduce Suicidal Ideation Among High-Risk Transition-Age Youth: Open-Label, Single-Arm, Phase 1 Clinical Trial.

BACKGROUND: The transition from adolescence to adulthood (18 to 25 years) is associated with an increased risk of suicidal ideation and behaviors. Suicide-focused cognitive behavioral therapies (CBTs) have been shown to significantly reduce suicidal ideation and behaviors but are not widely available to high-risk individuals. Digital therapeutics could improve access to these treatments. OBJECTIVE: This study aimed to evaluate the acceptability, safety, and potential efficacy of OTX-202 among transition-age youth (18 to 25 years) receiving mental health care outside an inpatient hospital setting. METHODS: In this phase 1 single-arm clinical trial, 59 transition-age youth with recent suicidal ideation or suicide attempts used OTX-202, a smartphone app designed to deliver suicide-focused CBT, concurrently with usual outpatient mental health care. After baseline, eligible patients completed 12 weekly assessments of suicidal ideation, depression, and anxiety. RESULTS: From baseline to week 12, participants reported statistically significant, large reductions in suicidal ideation (mean difference -5.1, 95% CI -6.5 to -3.7; d=0.95). In total, 3 (5.1%; 95% CI 0%-11.2%) participants reported suicide attempts. Reductions in suicidal ideation and suicide attempt rates were consistent with results from previously published randomized clinical trials of suicide-focused CBTs. Participants rated OTX-202 in the 97th percentile of usability and completed a mean of 9.0 (SD 3.5) of 12 app modules, supporting the app's acceptability. There were no patient deaths, device-related events, or severe adverse events, supporting the app's safety. CONCLUSIONS: Results support the safety, acceptability, and potential efficacy of OTX-202 for reducing suicide risk among transition-age youth. TRIAL REGISTRATION: ClinicalTrials.gov NCT06008132; https://clinicaltrials.gov/study/NCT06008132.